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RCKT's IND for RP-A701 in Dilated Cardiomyopathy Gets FDA Clearance
ZACKS· 2025-07-01 16:57
Core Insights - Rocket Pharmaceuticals (RCKT) has received FDA clearance for its investigational new drug application to initiate clinical studies for its gene therapy candidate RP-A701, aimed at treating BAG3-associated dilated cardiomyopathy [1][6] - The planned phase I study will assess the safety, biological activity, and preliminary efficacy of RP-A701 in adults with BAG3-DCM, a rare genetic heart condition [2][6] Company Pipeline - RCKT is also developing another gene therapy candidate, RP-A601, which is in early-stage development for arrhythmogenic cardiomyopathy [3] - Recent setbacks in the company's pipeline, including a voluntary pause in the phase II study of RP-A501 due to a patient death, have raised concerns [4][7] - The FDA has issued a complete response letter regarding the biologics license application for Kresladi, requesting additional information [8] Stock Performance - Year to date, RCKT's shares have declined by 80.5%, contrasting with a 3.6% decline in the industry [3] - The company currently holds a Zacks Rank of 3 (Hold), while other biotech stocks like Exelixis, Spero Therapeutics, and Puma Biotechnology have better rankings [9]
ABBV to Boost Immunology Pipeline With Capstan Buyout for $2.1B
ZACKS· 2025-07-01 15:05
Core Viewpoint - AbbVie has entered into a definitive agreement to acquire Capstan Therapeutics for up to $2.1 billion in cash, aiming to enhance its immunology pipeline with innovative therapies [1][7]. Acquisition Details - The acquisition will incorporate Capstan's lead asset, CPTX2309, which is a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy currently in phase I development for treating B-cell-mediated autoimmune diseases [2][3]. - Capstan's proprietary tLNP platform technology, CellSeeker, will also be added, facilitating RNA delivery to engineer specific cell types within the body [2][7]. - The acquisition is subject to customary closing conditions, including regulatory approvals [3]. AbbVie's Acquisition Strategy - AbbVie has been actively pursuing acquisitions to strengthen its pipeline, particularly in the immunology sector, while also exploring early-stage deals in oncology and neuroscience [4]. - Since the beginning of 2024, AbbVie has signed over 20 early-stage deals, focusing on promising technologies that can enhance care standards in immunology, oncology, and neuroscience [4]. Recent Acquisitions - Earlier in 2024, AbbVie acquired rights to develop GUB014295 (ABBV-295), a long-acting amylin analog for obesity treatment, marking its entry into the obesity market [5]. - In January 2025, AbbVie completed the acquisition of Nimble Therapeutics, adding an investigational oral peptide IL23R inhibitor for psoriasis treatment and a proprietary peptide synthesis platform for autoimmune diseases [8].
INVESTOR ALERT: Pomerantz Law Firm Reminds Investors with Losses on their Investment in Iovance Biotherapeutics, Inc. of Class Action Lawsuit and Upcoming Deadlines - IOVA
GlobeNewswire News Room· 2025-07-01 14:00
NEW YORK, July 01, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Iovance Biotherapeutics, Inc. (“Iovance” or the “Company”) (NASDAQ: IOVA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. The class action concerns whether Iovance and certa ...
IGM Biosciences Enters into Agreement to Be Acquired by Concentra Biosciences for $1.247 in Cash per Share Plus a Contingent Value Right
Globenewswire· 2025-07-01 12:58
Core Viewpoint - IGM Biosciences, Inc. has entered into a definitive merger agreement with Concentra Biosciences, LLC, where Concentra will acquire IGM Biosciences for $1.247 in cash per share, along with contingent value rights [1][2] Group 1: Merger Agreement Details - The acquisition price includes $1.247 in cash per share of IGM Biosciences common stock and one non-tradeable contingent value right (CVR) [1] - The CVR entitles holders to receive 100% of IGM Biosciences' closing net cash exceeding $82.0 million and 80% of net proceeds from the disposition of certain product candidates and intellectual property within one year post-closing [1] - The IGM Biosciences Board of Directors has unanimously approved the merger agreement, deeming it in the best interests of all stockholders [2] Group 2: Tender Offer and Closing Conditions - Concentra will initiate a tender offer by July 16, 2025, to acquire all outstanding shares of IGM Biosciences common stock [3] - The closing of the tender offer is contingent upon the tender of voting common stock representing at least a majority of outstanding shares and the availability of at least $82.0 million in cash [3] - The merger transaction is anticipated to close in August 2025, subject to customary closing conditions [3] Group 3: Legal Advisors - Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal counsel for IGM Biosciences, while Gibson, Dunn & Crutcher LLP is acting as legal counsel for Concentra [4]
TuHURA Biosciences, Inc. Announces Inclusion in the Russell 3000® and Russell 2000® Indexes
Prnewswire· 2025-07-01 12:50
Core Points - TuHURA Biosciences, Inc. has been added to the Russell 3000® Index and automatically included in the Russell 2000® Index as part of the 2025 annual reconstitution, effective June 27, 2025 [1][2] - The inclusion in the Russell indexes signifies the company's progress in its first year as a publicly traded entity and reflects its potential for continued development [2] - TuHURA is currently enrolling patients in a Phase 3 accelerated approval trial of its lead product IFx-2.0, which is being tested as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel cell carcinoma [2][11] - The company has also acquired a novel anti-VISTA antibody from Kineta, Inc. and plans to advance it into a Phase 2 clinical trial for treating NMPL1-mutated Acute Myeloid Leukemia [2] Company Overview - TuHURA Biosciences, Inc. is focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing both primary and acquired resistance [10] - The company's lead product, IFx-2.0, is designed to enhance the effectiveness of checkpoint inhibitors [11] - TuHURA is also leveraging its Delta Opioid Receptor technology to create bi-specific antibody drug conjugates aimed at inhibiting immune suppression in the tumor microenvironment [12]
BioMarin Announces Completion of Acquisition of Inozyme
Prnewswire· 2025-07-01 12:45
SAN RAFAEL, Calif., July 1, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) said today that it completed the previously announced agreement to acquire Inozyme Pharma, Inc. (Nasdaq: INZY) for $4.00 per share in an all-cash transaction worth approximately $270 million. The acquisition will strengthen BioMarin's enzyme therapies portfolio, adding a late-stage enzyme replacement therapy, INZ-701. The medicine is currently being developed for the treatment of ectonucleotide pyrophosphatase/phosp ...
Evaxion announces changes to Executive Management to optimize the value of proprietary AI-Immunology™ platform and portfolio
Globenewswire· 2025-07-01 12:30
Core Insights - Evaxion A/S announces key executive management changes to enhance value from its AI-Immunology™ platform and pipeline [1] - Christian Kanstrup steps down as CEO, with Dr. Birgitte Rønø appointed as interim CEO while a search for a new permanent CEO begins [2][5] - Thomas Schmidt is appointed as the permanent CFO, having previously served as interim CFO since November 2024 [3][4] Management Changes - The company is actively searching for a new CEO with a strong focus on business development and transformational leadership [5] - Dr. Rønø has been with Evaxion since 2017 and has significant experience in scientific and strategic roles [2] - Thomas Schmidt's financial expertise is expected to support the company's operations and leadership during this transition [4] Company Overview - Evaxion is a clinical-stage TechBio company that utilizes its AI-Immunology™ platform to develop vaccines targeting cancer, bacterial diseases, and viral infections [7] - The company has a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline for infectious diseases, addressing high unmet medical needs [7]
Indaptus Therapeutics, Inc. Announces Additional Sale of $3.4 Million in Private Placement of Convertible Notes and Warrants
Globenewswire· 2025-07-01 12:14
Core Points - Indaptus Therapeutics, Inc. has raised a total of $5.7 million through the sale of convertible promissory notes and accompanying warrants [1][2] - The notes have a 6% annual interest rate and will mature on July 28, 2026, with conversion into common stock at a price equal to 80% of the average Nasdaq closing price for the five trading days prior to conversion, capped at $11.20 [2] - Warrants to purchase 200% of the conversion shares will be issued upon conversion, with an exercise price equal to the conversion price and a term of five years [3] - The net proceeds from the offering will be used for research and development activities, including funding a Phase 1b/2 clinical trial, as well as for working capital and general corporate purposes [4]
Aptose Upgraded to Trade on OTCQB Market
Globenewswire· 2025-07-01 12:00
Aptose will trade under the ticker symbol APTOF and begin trading on OTCQB today, July 1stSAN DIEGO and TORONTO, July 01, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS) based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), announced today that the Company has been upgraded to list for trading on the OTCQB Market under the ticker “A ...
Oncternal Therapeutics Announces the Sale of Select Development Programs and the Wind-Down of its Operations
GlobeNewswire News Room· 2025-07-01 12:00
SAN DIEGO, July 01, 2025 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. today announced the sale of its zilovertamab and ONCT-808 programs to Ho’ola Therapeutics, Inc. Zilovertamab is an investigational monoclonal antibody designed to inhibit the function of Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1), and ONCT-808 is an investigational autologous chimeric antigen receptor T (CAR T) cell therapy that targets ROR1 using the binding domain from zilovertamab. Ho’ola will pay Oncternal a $3.0 milli ...